End-to-end CDMO development and scalable synthesis of therapeutic oligonucleotides, phosphoramidite building blocks, and targeted conjugates. From ASOs and siRNAs to GalNAc-ligated constructs, we ensure precise sequence fidelity, high coupling efficiency, and rigorous downstream purification.
Therapeutic Oligonucleotide Development & Manufacturing
Scalable Solid-Phase Synthesis, Modified Chemistries & Targeted Delivery Platforms
At Anax Laboratories, our oligonucleotide manufacturing platform delivers comprehensive contract development and manufacturing (CDMO) solutions for RNA- and DNA-based therapeutics. We support biopharma innovators across preclinical discovery, clinical trials, and commercial scale-up with high-purity antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), microRNAs (miRNAs), and aptamers.
1. Core Synthesis Platforms & Scale-Up Capacities
- Scalable Solid-Phase Synthesis: Automated synthesizers supporting column dimensions from millimole research quantities to multi-kilogram commercial batches.
- In-House Building Block Synthesis: Custom synthesis and scale-up of standard and non-standard DNA/RNA phosphoramidites, modified nucleosides, and solid support resins (CPG and polystyrene).
- High Coupling Efficiency: Optimized coupling protocols delivering step-wise coupling yields exceeding 99.0% to minimize truncated n-1 and n+1 sequence impurities.
2. Modified Chemistries & Conjugation Modalities
- Backbone Modifications: Phosphorothioate (PS) backbone stereocontrol and phosphorodiamidate morpholino oligomer (PMO) synthesis for improved enzymatic nuclease resistance.
- Ribose Sugar Modifications: High-yield integration of 2′-O-Methyl (2′-OMe), 2′-O-Methoxyethyl (2′-MOE), 2′-Fluoro (2′-F), and Locked Nucleic Acids (LNA) to maximize target binding affinity and systemic half-life.
- Targeted Delivery Conjugation: Integrated synthesis and coupling of triantennary GalNAc (N-Acetylgalactosamine) clusters for liver-targeted therapeutics, lipid conjugates (cholesterol, palmitic acid), and cell-penetrating peptides (CPPs).
3. Downstream Purification & Isolation
- Preparative Chromatography: Multi-stage purification utilizing high-resolution Ion-Exchange Chromatography (IEX-HPLC) and Reverse-Phase HPLC (RP-HPLC) for high-resolution single-strand and duplex separation.
- Ultrafiltration & Diafiltration (UF/DF): Enclosed Tangential Flow Filtration (TFF) systems for continuous desulfurization, desalting, and counter-ion exchange (sodium or potassium salt forms).
- Controlled Lyophilization: Large-scale freeze-drying infrastructure ensuring low residual moisture, controlled bioburden, and stable end-product morphology.
4. Analytical Characterization & Release
- Sequence Fidelity & Mass Verification: High-Resolution LC-MS/MS (intact mass determination and MS/MS sequence mapping).
- Purity & Impurity Profiling: Capillary Gel Electrophoresis (CGE), IP-RP-HPLC, and strong anion exchange (SAX) HPLC for n-1 shortmer and n+1 longmer clearance.
- Safety & Compendial Testing: Validated endotoxin (LAL), bioburden, residual organic solvents (GC-HS), and elemental impurities (ICP-MS) complying with ICH guidelines.